Summary:
Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Dermatology Associates & Surgery Center on November 17, 2022, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review, observation, and interview the laboratory failed to ensure that reagents used in the staining process were not expired for one of 6 reagents utilized. Findings: 1. A review of reagent log records identified lot #155275 of Eosin reagent with an expiration date of 7/31/2024 documented as the current lot in use. 2. A tour of the laboratory identified lot #098060 of Eosin reagent with an expiration date of 4/30 /2022 as the opened, current lot in use for the H&E staining process. Lot #155275 of Eosin reagent was sealed. 3. An interview with the laboratory manager, 11/17/22 at approximately 10:30 AM, confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --